Job description
Qualification Engineer – HVA, Clean Rooms, Clean Utilities
Position Summary
The Qualification/Validation Engineer, as part of the project Validation team, will be responsible for the timely qualification of assigned systems. This includes a large variety of systems, being the typical biopharmaceutical processing systems (bioreactors, centrifuges, buffer/media vessels, chromatography columns, filtrations skid etc.) as well as utilities, HVAC, parts washers and autoclaves.
The role will involve working as part of the larger CQV organization and engaging with various groups and departments including construction, manufacturing, quality, engineering and commissioning.
General Scope of Responsibilities
The role of the Validation Engineer will be one of direct responsibility, on behalf of Genzyme, for the successful qualification of defined systems. Reporting to the project Qualification Lead, the role of the Qualification Engineer will be to:
Participate in the project Validation team to successfully execute start-up activities safely and to a high quality, based on the overall CQV schedule, for assigned systems.
Generate Validation documents (URS, Impact Assessments, IQ/OQ Protocols) for assigned systems in the paperless documentation system Kneat. The applied validation methodology is according to EU (Annex 15) and US (21CFR210/211/600) GMP regulations as well as specific internal company quality requirements.
Verify technical documentation (i.e. welding and material packages as delivered by vendors as well as passivation, air break and IO verification sheets documented by commissioning) as part of IQ execution.
Execute ‘as built’ field verifications based on P&ID’s.
Generate IQ/OQ reports for the executed qualification tests.
Ensure that design intent is met and proven through the execution of start-up activities.
Report at regular times on progress.
Engage with technical support functions (i.e. process, automation etc.) to resolve issues quickly as they arise through qualification execution.
Person Specification
Experience:
Essential
Knowledge of pharmaceutical plant qualification, preferably in a biotechnology process environment.
Knowledge of process & clean utility design.
Good understanding of the regulatory GMP requirements in EU and US for biotech operations (such as Eudralex, ICH, 21CFR) including area classifications (ISO 14644 and EU Annex 1).
Literate in computer operating systems and applications such as Windows, MS Word and Excel.
Preferred
Qualified with relevant technology degree (or equivalent).
Emerson Delta V automation system competency.
Knowledge of EU and US Pharmacopoeia.
Operating experience in the pharmaceutical industry, ideally in a biotechnology process environment.
Specific for this profile: relevant experience in qualification of HVAC, cleanrooms (incl. thermo-mappings), LAF systems, Clean Utilities, Parts Washers and Autoclaves.
Personal / Team Skills:
Essential
Able to communicate and write documentation in English.
Results oriented with good organizational skills.
Strong quality and safety focus
Excellent communication skills
Previous experience working in a team based environment
Supplementary Information
This position description is a general guideline; it does not purport to be an exhaustive list of all elements of the position. Management reserves the right to modify this position description at any time, or to vary the duties and responsibilities of the position to meet production, scheduling or other business needs.
On-site presence required
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
Amaris Consulting is proud to be an equal opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.
Who are we?
Amaris Consulting is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of 7,600 people spread across 5 continents and more than 60 countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.
At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here's what our recruitment process looks like:
Brief Call: Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!
Interviews (the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!
Case study: Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.
As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.
We look forward to meeting you!
